Clinical Study Associate Manager
- United States
- ICON Strategic Solutions
- Clinical Trial Management
- Remote
TA Business Specialist
- Icon Strategic Solutions
About the role
As a Clinical Study Associate Manager you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.
What you will be doing:
- May lead/oversee the planning and management of a clinical study in an assigned region(s) in alignment with the global study plans and may contribute to global planning and management of the study
- Contributes to risk assessment and helps identify risk mitigation strategies
- Supports feasibility assessment to select relevant regions and countries
- Oversees and provides input to the development of study specific documentation including but not limited to: case report form (CRF), data management plan, monitoring plan, monitoring oversight plan, etc.
- Reviews site level informed consents and other patient-facing study start-up materials
- Oversees setting up and maintenance of study systems including but not limited to Clinical Trial Management System (CTMS) and Trial Master File (TMF) Contributes to investigator meeting preparation and execution
- Oversees engagement, contracting and management of required vendors for the study
- Oversees and provides input to study drug and clinical supplies forecasting, drug accountability and drug reconciliation
- Provides regular status reports to stakeholders as requested by the Clinical Study Lead
- Contributes to development of and oversees implementation of recruitment and retention strategies
- Monitors recruitment and retention
- Monitors progress for site activation and monitoring visits
- Supports data quality including regular review of data metrics and listings, protocol deviations, eligibility violations, dosing deviations and suspected non-compliance by sites
- Escalates data flow and data quality issues to Clinical Study Lead
- Oversees the execution of the specific clinical study deliverables against planned timelines
- Escalates issues related to timelines or budget to Clinical Study Lead
- Supports accurate budget management and scope changes
- Contributes to clinical project audit and inspection readiness throughout the study lifecycle
- Supports internal and external inspection activities and contributes to CAPAs as required
- Manages aspects of study close-out activities including but not limited to database lock, reconciliation of vendor contract, study budget, TMF and study drug accountability
- May be responsible for mentoring clinical trial management staff
- May be assigned unmasked tasks for studies, which may include but is not limited to, assisting with masked investigational product, set up and management of unmasked trial master file, review of unmasked data in the electronic data capture system, point of contact for IVRS issues, and support oversight of unmasked clinical monitoring
- May require up to 20% travel
You are:
- Bachelors Degree and 4+ years of relevant industry experience.
- Excellent communication and interpersonal skills; ability to build relationships internally and externally
- A data driven approach to executing and problem solving
- Attention to details for the ability to deliver on specific study activities
- Technical proficiency in trial management systems and MS applications including (but not limited to) Project, PowerPoint, Word, Excel, IVRS/IWRS, EDC, TMF
- Proactive and self-disciplined, ability to meet deadlines, effective use of time, and prioritization
- Budget awareness with the ability to participate in various aspects of budget management
- Familiarity with medical terms
- Vendor management experience
- Experience in clinical trial operations including experience developing key study documents
- Knowledge of ICH/GCP and regulatory guidelines/directives
What ICON can offer you:
Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.
In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.
Our benefits examples include:
- Various annual leave entitlements
- A range of health insurance offerings to suit you and your family’s needs
- Competitive retirement planning offerings to maximise savings and plan with confidence for the years ahead
- Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being
- Life assurance
- Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others
Visit our careers website to read more about the benefits of working at ICON: https://careers.iconplc.com/benefits
At ICON, diversity, inclusion & belonging are fundamental to our culture and values. Our rich diversity makes us more innovative which helps us better serve our people, patients, customers, and our communities. We're proud of our diverse workforce and the work we’ve done to become a more inclusive organisation. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know through the form below.
https://careers.iconplc.com/reasonable-accommodations
Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.
Impactful work. Meaningful careers. Quality rewards.
At ICON, our employees are our greatest strength. That’s why we are committed to empowering you to live your best life, both inside and outside of work. Whether your ambition is lead a global team, become a deep scientific or technical expert, work in-house with our customers or gain experience in a variety of different ICON functions, we will support you in realising your full potential. See all locations Read more
Day in the life
Teaser label
Career ProgressionContent type
BlogsPublish date
05/10/2024
Summary
Although many employers are returning to the office, we’re still seeing a mix of both video and in-person interviews in application processes. Early in 2020, the number of companies using video interv
Teaser label
Our PeopleContent type
BlogsPublish date
08/29/2023
Summary
To excel as a Clinical Research Associate (CRA) in a Clinical Research Organization (CRO), you need a combination of education, skills, and the right mindset. Brazil-based CRA II Debora shares her
Teaser label
Career ProgressionContent type
BlogsPublish date
07/20/2023
Summary
Unlocking your Potential: The Benefits of ICON’s EPIC Internship Program Internship programs have become a vital stepping stone for students and young professionals seeking to gain practic
Similar jobs at ICON
Salary
Location
United States
Department
Clinical Trial Management
Location
United States
Remote Working
Remote
Business Area
ICON Strategic Solutions
Job Categories
Clinical Trial Management
Job Type
Permanent
Description
As a Clinical Trial Manager you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.
Reference
2024-113881
Expiry date
01/01/0001
Author
Brendan HoeyAuthor
Brendan HoeySalary
Location
Greece
Department
Clinical Trial Management
Location
Greece
Business Area
ICON Strategic Solutions
Job Categories
Clinical Trial Management
Job Type
Permanent
Description
As a Clinical Trial Manager you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.
Reference
2024-114422
Expiry date
01/01/0001
Author
Alexander SourounisAuthor
Alexander SourounisSalary
Location
United States, Canada
Department
Clinical Trial Management
Location
Canada
United States
Remote Working
Remote
Business Area
ICON Strategic Solutions
Job Categories
Clinical Trial Management
Job Type
Permanent
Description
As a Global Clinical Project Manager you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.
Reference
2024-114343
Expiry date
01/01/0001
Author
Monica HawkinsAuthor
Monica HawkinsSalary
Location
United States, Canada
Department
Clinical Trial Management
Location
Canada
United States
Remote Working
Remote
Business Area
ICON Strategic Solutions
Job Categories
Clinical Trial Management
Job Type
Permanent
Description
As a Global Clinical Project Manager you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.
Reference
2024-114344
Expiry date
01/01/0001
Author
Monica HawkinsAuthor
Monica HawkinsSalary
Location
United States, Canada
Department
Clinical Trial Management
Location
Canada
United States
Remote Working
Remote
Business Area
ICON Strategic Solutions
Job Categories
Clinical Trial Management
Job Type
Permanent
Description
As a Senior Clinical Trial Manager you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.
Reference
2024-114315
Expiry date
01/01/0001
Author
Monica HawkinsAuthor
Monica HawkinsSalary
Location
Mexico, Mexico City
Department
Clinical Trial Management
Location
Sao Paulo
Santiago
Bogota
Mexico City
Lima
Remote Working
Hybrid: Office/Remote
Business Area
ICON Full Service & Corporate Support
Job Categories
Clinical Trial Management
Job Type
Permanent
Description
We are currently seeking a Clinical Trial Manager II to join our diverse and dynamic Biotech team with a therapeutic alignment of Gen Med including MASH/NASH, Rare Disease studies, etc responsible for
Reference
JR122763
Expiry date
01/01/0001
Author
Tina GeerAuthor
Tina Geer